global® total® for Fertilization with Human Serum Albumin (HSA)

READY-TO-USE
LGTF-050, 50 ml

Indications for Use

Human oocyte culture and fertilization.

Storage and Shelf Life

Store at 2-8°C and protected from light. Ten (10) weeks from the date of manufacture. For best results, use within four (4) weeks.

Composition

Sodium Chloride; Sodium Pyruvate; Potassium Chloride; Calcium Chloride; Potassium Phosphate; Magnesium Sulfate; Sodium Bicarbonate; Amino Acids; EDTA; Glucose; Phenol Red; Sodium Lactate; Human Serum Albumin (4.4 mg/ml); Human α- and β-globulins (0.6 mg/ml); Gentamicin Sulfate (10 µg/ml)

Quality Control Specifications
Paramater Specification
pH (with 5% CO2) 7.2 — 7.4
Osmolality 260 — 270
LAL Endotoxin ≤ 0.5 EU/ml
Sterility Test, membrane filtration Negative
1-cell Mouse Embryo Assay (% blastocysts at 96 h of culture) ≥ 80%
Precautions and Warnings
  1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  2. Caution: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using global® total® for Fertilization for the culture and conventional in-vitro fertilization of human oocytes.
  3. Not to be used for injection.
  4. Do not use the product if:
    • the product packaging appears damaged or if the seal is broken
    • the expiry date has been exceeded
    • the product becomes discolored, cloudy, or shows evidence of particulate matter
  5. This product contains human serum albumin, a derivative of human blood. The human serum albumin used in the preparation of this product has been heated at 60°C for ten hours.
    Caution: All blood products should be treated as potentially infectious. Source material from which this product was derived was found negative when tested for antibodies to HIV, HBc, HCV, and HTLV I/II and non-reactive for HbsAg, HCV RNA and HIV-1 RNA and syphilis. No known test methods can offer assurances that products derived from human blood will not transmit infectious agents.
  6. global® total® for Fertilization contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
  7. To avoid problems with contamination, practice aseptic techniques.
  8. Discard unused medium within 7 days of opening. Do not use after expiry date.
Recommendations for Use